Data / Medical devices / United States / Aspyra, LLC.
Aspyra, LLC.: FDA-registered device maker in Jacksonville, FL, United States, 2 510(k) clearances
Aspyra, LLC. is registered with the FDA (registration 1063008) in Jacksonville, FL, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 18, 2010. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1063008
- FEI number
- 3001452787
- Address
- 7400 Baymeadows Way Ste 101, Jacksonville, FL, United States, 32256
- Owner or operator
- Aspyra, LLC (10034590)
- Roles
- Manufacturer
- First device listed
- December 14, 2010
- Registered through
- 2026
- Brand names listed
- AccessMed, AccessNET, AccessNet, AccessRad, CyberLAB, CyberLab, CyberPATH, CyberPath and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Digital Image Storage, Radiological | LMB | 1 | Manufacturer | accessdata.fda.gov |
| Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System | NVV | 1 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 18, 2010 | K091631 | ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW | LLZ | Substantially Equivalent | Aspyra, Inc. | accessdata.fda.gov |
| January 2, 1998 | K973805 | IMAGEACCESS SYSTEM | LMD | Substantially Equivalent | Storcomm, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 31, 2007 | 37277 | Not yet classified | Terminated | Aspyra, Inc. CyberMED Version 2.1 Pharmacy Software | Medications prescribed for one patient were printed on the Medication Administration Record (MAR) of another patient. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of Device, Digital Image Storage, Radiological
- All makers of Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
- All makers of System, Image Processing, Radiological
Updated March 18, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.